1. Provide leadership and direction for the development, management and improvement of robust Quality Systems throughout the company
2. Directly lead and manage the Quality Assurance and Quality Control groups
3. Provide strategic direction regarding processes, procedures and quality standards required to maintain compliance to applicable regulations.
4. Work with other departments to write and maintain SOPs and then ensure compliance with applicable SOPs, regulations and guidances.
5. Ensure an “inspection ready” state is maintained across all GMP activities.
6. Provide oversight for GMP audits (internal/external) to assure adherence to SOPs and applicable regulations.
7. Manage vendor qualification oversight of contracted and purchased services and material.
8. Ensure that appropriate corrective/preventive actions are taken as a result of audit or inspection observations.
9. Perform formal risk assessments internally, as well as with selected contract providers; determine audit intervals and establish level of risk based on this assessment.
10. Develop and manage quality assurance and quality control personnel
11. Responsible person for ensuring success on all on-site inspections and audits from clients and regulatory agencies.
1. Education and Experience(hard skills)
2. B.S. or higher in chemistry, biology or other relevant field
3. 15+ years of experience in a manufacturing environment
4. 10+ years of experience in cGMP quality with progressive increase in responsibilities
5. Quality systems management
6. Experience in analytical or quality control
7. Good working knowledge of Chinese and US FDA regulations
8. Demonstrated personnel management experience
9. English language proficiency (written and verbal)
10. Demonstrated leadership abilities
11. Excellent interpersonal skills
12. Highly organized
13. Proficient in computer programs (Microsoft Office, audit trail, analytical instruments and lab management software etc.)